HealthyPhase 3NCT00356382
Decreasing Rates of Illness in Kids (DRINK)
A Phase 3 study testing Lactobacillus (L.) casei in people with Healthy, run by Georgetown University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of a cultured dairy drink with high concentrations of active L casei to reduce the cumulative rate of illness in daycare/school children ages 3 to 6. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lactobacillus (L.) casei
- How many people
- 638 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jun 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female
- Aged 3 to 6 years
- Attending daycare centers or school 5 days a week
- Subjects or parents/legal guardians who agree to have their child refrain from consuming dairy fermented products during the course of the study
Who cannot join
- Subjects whose caregivers do not speak English or Spanish
- Subjects with allergy or hypersensitivity to milk proteins or dairy food components like lactose
- Subjects that do not have proper storage facility for product to be held at home
- Subjects presenting with a chronic disease that requires daily medication (Ex. cancer, tuberculosis, Crohns disease, cirrhosis, multiple sclerosis, Type 1 Diabetes...)
- Subjects with cardiac, respiratory, or renal insufficiencies
- Subjects with chronic immunodeficiency (ex: HIV, Chemotherapy...)
Show all 22Show fewer
- Subjects presenting any infection in the last 7 days
- Subjects with any current or past severe gastrointestinal or metabolic disease (malabsorption, ulcer, celiac disease...)
- Subjects with a history of severe respiratory disease that requires daily usage of medicine
- Subjects that used laxatives in the last 7 days
- Subjects currently with diarrhea or constipation in the last 7 days
- Subjects under artificial nutrition or that were under artificial nutrition in the last 2 months
- Subjects with special medicated diet (obesity, anorexia, metabolic pathology...)
- Subjects with eating disorders (anorexia, bulimia...)
- Subjects currently receiving, or that received in the last 7 days, any antibiotics, antiseptics, antifungals, corticosteroids, vaccines, anti histamines, non steroid anti-inflammatory drugs
- Subjects that had a gastro-intestinal surgery in the last 3 months
- Subjects that had any surgery or intervention requiring general anaesthesia in the last month
- Subjects enrolled in another clinical study, currently or during the last 2 months (exclusion period from the former study)
- Subjects presenting congenital malformation
- Subjects with failure to thrive, growth retardation, or any developmental problem
- Subjects not attending day care centers or schools 5 days a week
- Subjects who cannot obtain both of their parents/legal guardians' signatures if they are separated/divorced and have joint custody of the child
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Department of Family Medicine
Washington D.C., District of Columbia, 20007
About this study
Official title: Decreasing Rates of Illnesses in Kids (DRINK)
The purpose of this study is to determine the effectiveness of a cultured dairy drink with high concentrations of active L casei to reduce the cumulative rate of illness in daycare/school children ages 3 to 6.
Read the detailed description
Probiotics are live microorganisms, which when administered in sufficient amounts, may improve health. Often, probiotics are ingested as supplements in powder, pill, or liquid form, designed specifically for medicinal benefit. Such supplements used in children have shown some potential benefits in the treatment and prevention of various diseases, including diarrhea, asthma, necrotizing enterocolitis and allergies.
In the past few years, interest has increased in the health-enhancing role f specific foods, referred to as functional foods- foods providing health benefits beyond their nutritional value. Yogurt, a fermented milk product produced by the action of two bacteria, Lactobacillus (L.) bulgaricus and Streptococcus (S.) thermophilus, is a functional food. In fact, two-thirds of primary care physicians, who counsel patients about nutrition, recommend consuming yogurt containing live active cultures for their patients' health benefit. However, evidence for these health outcomes is not sufficiently strong.
Daycare and school centers are ideal places for the transmission of respiratory infections and childhood diarrhea, often resulting in many missed days of both daycare and parental work. Illnesses related to daycare centers have been estimated to cost $1.8 billion per year in the United States. One of the primary purposes of daycare is to allow parents to work while their child is taken care of, thus, absences due to illnesses have many direct and indirect associated costs. Unfortunately, children in daycare centers have been shown to have more outpatient doctor visits, emergency room visits, and increased usage of prescription medicines than children in daycare.
Our overall goal is to study a cultured dairy drik with an efficacious probiotic at doses that result in probiotic survival in the gastrointestinal tract and subsequently reduce illnesses in daycare/school children ages 3-6.
The rationale for focusing on a drink as a vehicle for transmission of probiotics, is that it has the potential for a much greater public health impact than using probiotics in a medicinal manner, such as pills or capsules. Yogurt and yogurt like probiotic drinks are well established and popular with children and parents, a product that traditionally provides live cultures to the diet, and can provide protein, vitamins and minerals that are nutritious for the child. Additionally, these drinks are relatively inexpensive, widely available, and easy to ingest even for individuals with lactose intolerance. These positive attributes make it an idea carrier to deliver the health benefits of probiotics.
- Conditions
- Healthy
- Being tested
- Lactobacillus (L.) casei
- Keywords
- probiotic, Lactobacillus (L.) casei, cultured dairy drink, Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus (L.) caseiDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of sick days due to upper-respiratory and gastro-intestinal infections and diarrhea.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 638 participants
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Dannon Company, Inc.
- Investigators
- Daniel Merenstein, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356382
- Sponsor's protocol ID
- 2006-291
- Status last verified
- Apr 2007
- First submitted
- 24 Jul 2006
- Last updated
- 14 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Rates of Illnesses in Kids (DRINK)
- ClinicalTrials.gov ID
- NCT00356382
- Acronym / sponsor ID
- 2006-291
- Conditions
- Healthy
- Keywords
- probiotic, Lactobacillus (L.) casei, cultured dairy drink, Health
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 638 participants
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Dannon Company, Inc.
- Study start
- Sep 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 26 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of a cultured dairy drink with high concentrations of active L casei to reduce the cumulative rate of illness in daycare/school children ages 3 to 6.
Detailed description
Probiotics are live microorganisms, which when administered in sufficient amounts, may improve health. Often, probiotics are ingested as supplements in powder, pill, or liquid form, designed specifically for medicinal benefit. Such supplements used in children have shown some potential benefits in the treatment and prevention of various diseases, including diarrhea, asthma, necrotizing enterocolitis and allergies.
In the past few years, interest has increased in the health-enhancing role f specific foods, referred to as functional foods- foods providing health benefits beyond their nutritional value. Yogurt, a fermented milk product produced by the action of two bacteria, Lactobacillus (L.) bulgaricus and Streptococcus (S.) thermophilus, is a functional food. In fact, two-thirds of primary care physicians, who counsel patients about nutrition, recommend consuming yogurt containing live active cultures for their patients' health benefit. However, evidence for these health outcomes is not sufficiently strong.
Daycare and school centers are ideal places for the transmission of respiratory infections and childhood diarrhea, often resulting in many missed days of both daycare and parental work. Illnesses related to daycare centers have been estimated to cost $1.8 billion per year in the United States. One of the primary purposes of daycare is to allow parents to work while their child is taken care of, thus, absences due to illnesses have many direct and indirect associated costs. Unfortunately, children in daycare centers have been shown to have more outpatient doctor visits, emergency room visits, and increased usage of prescription medicines than children in daycare.
Our overall goal is to study a cultured dairy drik with an efficacious probiotic at doses that result in probiotic survival in the gastrointestinal tract and subsequently reduce illnesses in daycare/school children ages 3-6.
The rationale for focusing on a drink as a vehicle for transmission of probiotics, is that it has the potential for a much greater public health impact than using probiotics in a medicinal manner, such as pills or capsules. Yogurt and yogurt like probiotic drinks are well established and popular with children and parents, a product that traditionally provides live cultures to the diet, and can provide protein, vitamins and minerals that are nutritious for the child. Additionally, these drinks are relatively inexpensive, widely available, and easy to ingest even for individuals with lactose intolerance. These positive attributes make it an idea carrier to deliver the health benefits of probiotics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female
- Aged 3 to 6 years
- Attending daycare centers or school 5 days a week
- Subjects or parents/legal guardians who agree to have their child refrain from consuming dairy fermented products during the course of the study
Key exclusion criteria (22 listed)
- Subjects whose caregivers do not speak English or Spanish
- Subjects with allergy or hypersensitivity to milk proteins or dairy food components like lactose
- Subjects that do not have proper storage facility for product to be held at home
- Subjects presenting with a chronic disease that requires daily medication (Ex. cancer, tuberculosis, Crohns disease, cirrhosis, multiple sclerosis, Type 1 Diabetes...)
- Subjects with cardiac, respiratory, or renal insufficiencies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus (L.) casei | Drug | – |
Primary outcome
Mean of sick days due to upper-respiratory and gastro-intestinal infections and diarrhea.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Merenstein, MD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lactobacillus (L.) casei in people with Healthy, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of sick days due to upper-respiratory and gastro-intestinal infections and diarrhea.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2008.